Healthy Volunteers
Conditions
Brief summary
This study evaluated the inter- and intra-rater reliability of the GEBA Scale with photonumeric guide for the assessment of overall eyebrow fullness. There is no treatment (intervention) associated with this study.
Interventions
DRUGNo Intervention
No Intervention.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Willing to remove makeup and jewelry at each visit * Willing to have photographs taken of the facial area
Exclusion criteria
* Permanent eyebrow makeup (i.e., tattooing) or eyebrow implants of any kind * Eyebrow extension application within 3 months of study entry * Eyebrow tint or dye application within 2 months of study entry * Eyebrow grooming (i.e., tweezing, waxing, or threading) between visits that is not part of the current routine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale | Day 1 | Inter-rater agreement (among raters) of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters scored 112 subjects' eyebrows using the GEBA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall's W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kendall's W was provided. |
| Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale | Day 1 | Intra-rater (within raters) agreement of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 raters who evaluated 112 subjects using GEBA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics was provided. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Healthy volunteers. No treatment (intervention) was received. | 112 |
| Total | 112 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 44.3 Years |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale
Inter-rater agreement (among raters) of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters scored 112 subjects' eyebrows using the GEBA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall's W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kendall's W was provided.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale | 0.889 Kendall's W |
Primary
Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale
Intra-rater (within raters) agreement of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 raters who evaluated 112 subjects using GEBA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics was provided.
Time frame: Day 1
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale | 0.807 Kappa statistics |